During a gastrointestinal endoscopic procedure, the operator often desires to repair or reconstruct a tear or defect or otherwise approximate or fixate tissue or other material by suturing.
Metallic clipping devices were first introduced for the primary purpose of achieving hemostasis of focal gastrointestinal bleeding. Indications for their use have expanded to include closure of perforations and fistulas, securing of catheters and stents, and as a marking device to direct endoscopic, surgical, and radiological therapy, among others. Several endoscopic clipping devices are commercially available. All consist of metallic double or triple prongs joined at the proximal end. The prongs of the clip are applied with pressure onto the target tissue and pinched closed by manually squeezing the catheter handle assembly. Clipping devices are limited by a fixed distance and relationship between the prongs.
The fixed distance between the prongs limits the operator's ability to close defects that exceed this distance, which limits applicability to small defects. The fixed relationship between the prongs limits the operator's ability to position the dip appropriately in relation to the area in need of treatment. For instance, the clips may not be able to close a defect that is approached tangentially at a curve or angle. Further, because the proximal ends of the legs are joined, the operator may not be able to adjust the positioning of one clip prong without affecting the positioning of the second. Positioning also may be limited because the clip may not be properly oriented when it is deployed or the clip may slip out of alignment during application. Finally, the legs of presently-used clips must be actuated and anchored at the same time. If unequal pressure is applied to the legs during anchoring, closure may be sub-therapeutic and scissoring of the legs may occur that can result in tissue damage. Presently-used clips are only capable of capturing the mucosa and do not penetrate into the deeper wall layers (submucosa and muscular propria layers).
A suturing device that addresses the limitations of clips is the Apollo Overstitch. This device provides a curved needle movable on an arm to pierce tissue and perform tissue approximation and suturing. This device is capable of full-thickness (entire bowel wall) tissue capture and the closure of larger defects, however, the device cannot be delivered through the working (operative) channel of the endoscope and must be pre-mounted on the end of the endoscope. It also involves multiple time consuming, technically demanding maneuvers and manipulations. A need remains for an endoscopic tissue closure device which addresses the limitations of presently-used clips and is capable of full thickness tissue capture.
The Ovesco “over-the-scope-clip” (OTSC) can achieve full-thickness closure of a defect by suctioning tissue into a cap attachment mounted on the end of the endoscope. The clip, mounted on the cap attachment, is released by turning a hand wheel, similar to band ligation. The size of the defect that can be closed is small, limited by the diameter of the cap attachment. Like the Apollo Overstich, the OTSC must be pre-mounted onto the endoscope prior to use.
Accordingly, it would be desirable to obtain a multiple tissue anchor and delivery system for facilitating the repair of wall defects, plication of tissue, and treatment of lesions delivered through the working channel of the endoscope.
It would also be desirable to obtain a multiple tissue anchor and delivery system for repairing wall defects, plicating tissue, and treating lesions whereby the apparatus and methods have the capability to facilitate repairs of defects of any size, plicate tissue of any size, and treat lesions of any size, with deployment of each anchor independent of one another under direct endoscopic visualization.
It would also be desirable to obtain a multiple tissue anchor and delivery system to provide treatment of relatively large perforations, lesions and damage areas under endoscopic visualization.